Search Results

Ask a specific question about this device

Ask a specific question about this device

The Wearable Breast Pump (Model W2) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W2) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump (Model W2) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump, valve, control board, and milk collector. The user interface allows the user to switch from expression and massage modes and control the vacuum levels within those modes. The Wearable Breast Pump (Model W2) also includes a 'Hot Compress' mode not associated with any vacuum pressure or cycle speed. When enabled, the flange is heated, the symbol indicating heating will light up, and the maximum temperature is ≤ 42°C.

All available modes consist of 9 vacuum levels. The Wearable Breast Pump (Model W2) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 107-143 cycles per minute in massage mode and vacuum levels from 120-245 mmHg with cycling rates from 34-111 cycles per minute in expression mode. The Wearable Breast Pump (Model W2) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump (Model W12) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and massage modes and control the vacuum levels within those modes. The Wearable Breast Pump (Model W12) also includes a 'Hot Compress' mode not associated with any vacuum pressure or cycle speed. When enabled, the flange is heated, the symbol indicating heating will light up, and the maximum temperature is <= 42 degrees C.

All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model W12) is capable of providing vacuum levels from 40-150 mmHg with cycling rates from 86-127 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 34-109 cycles per minute in expression mode, vacuum levels from 40-245 mmHg with cycling rates from 34-130 cycles per minute in auto mode, and vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in massage mode. The Wearable Breast Pump (Model W12) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Motion InBra (YM-8801) wearable breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Motion InBra (YM-8801) powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

The Motion InBra (YM-8801) wearable breast pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Motion InBra (YM-8801) is a breast pump powered by lithium-ion battery, utilizing an embedded control program to manage all device functions. The user interface allows the user to switch from stimulation and expression modes and control the vacuum levels within those modes.

All available modes consist of 9 vacuum levels. The Motion InBra (YM-8801) is capable of providing vacuum levels from 80-160 mmHg with cycling rates from 100-120 cycles per minute in stimulation mode and vacuum levels from 80-280 mmHg with cycling rates from 35-75 cycles per minute in expression mode. The device is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adaptor if the motor unit is not in operation.

The Motion InBra Wearable Breast Pump includes 2-Phase Expression Technology: Stimulation and Expression Phases. The Stimulation Phase initiates with a rapid suction pattern designed to trigger the milk ejection reflex and promote milk flow. In contrast, the Expression Phase begins with a slower and deeper suction rhythm, optimized for effective milk extraction once let-down has occurred. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

The operating life of the Motion InBra Wearable Breast Pump is 150 hours. The expected operating life of the washable parts (milk container, breast shield, insert and membrane) is 3 months.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 175 and 21 CFR 177.

N/A

Ask a specific question about this device

The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Spectra S1 Pro and Spectra S2 Pro are comprised of the following components: pump unit, adapter, wide breast shield, back-flow protector, tubing, silicone valve, bottle cap, bottle screw, nipple, airtight cap, and PP bottle. The device is provided non-sterile.

The Spectra S1 Pro and Spectra S2 Pro support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

Spectra S1 Pro and Spectra S2 Pro includes the following features:

• Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
• Expression mode: 1-15 level (50-270 mmHg), cycle speeds (38, 42, 46, 50, 52, 58)
• Massage mode: 1-5 level (50-180 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra S1 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2000mAh). The Spectra S2 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) only.

When the backflow protector is assembled between the pump unit and the breast shield, the silicone membrane inside the backflow protector creates a physical barrier by preventing air and milk from flowing back into the pump unit.

All milk contacting components are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

Pump In Style Pro+ is a powered breast pump intended to be used in a home environment (or similar such as an office). It features 2-Phase Expression technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm.
Pump In Style Pro+ comprises a pump unit, which includes:

• User-adjustable controls: "On/Off" for powering on/off the device, "Let-down" for switching between pumping phases, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
• a port for connection of the tubing that channels the vacuum;
• a port for connection of the power supply;
• an internal, non-replaceable, rechargeable lithium-ion battery providing users the option to power the breast pump without reliance on a wall-connection or external power source;
• a LED battery status indicator which informs users of available charge;
• a pump phase LED status indicator which informs users of the active pump phase;
• vacuum level LED indicators (total of 16, one for each vacuum level).
  Pump In Style Pro+ is a double electric breast pump that can be used to extract breast milk from one breast at a time (i.e., single pumping) or from both breasts simultaneously (i.e., double pumping). A DC (direct current) motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk.
  The materials of the milk-contacting components are compliant with 21 CFR 177 and 21 CFR 178.

N/A

Ask a specific question about this device

The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.

The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Electric Breast Pump (Model YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Electric Breast Pump (Models YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is provided non-sterile and is reusable device intended for a single user in home healthcare environment.

The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The motor unit operates on a rechargeable Lithium battery (3.7V/1400mAh). The rechargeable battery can be charged from the external power adaptor specified in the User Manual (not included) through the provided USB charging cable. The user interface features four buttons (power, mode selection, vacuum level increase and decrease) and an LED display (current mode, level, timer and battery status), allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device includes four models that have same working principle and technology but differ in terms of their appearance, components, and materials. All device models have three modes of operation: Stimulation phase, Expression phase, Simulated sucking Phase, with nine levels in each mode. The Stimulation phase provides high cycle frequency and gentle suction, while the Expression phase provided slower cycles with higher vacuum pressures. The Simulated sucking phase provides a combination of the other two phases - two cycles in Expression phase followed by one Stimulation phase cycle, then three Expressions phase cycles followed by two in Stimulation phase to form one cycle.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Wearable electric breast pump (Model: YM-8803) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable electric breast pump (Model YM-8803) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. The device is provided not sterile and should be cleaned and disinfected according to the instructions for use.

The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk container.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adaptor specified in IFU (not included) through the provided USB charging cable. The user interface features four buttons and an LED display, allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device has two modes: Stimulation and Expression.

N/A

Ask a specific question about this device